Diseases such as venous insufficiency, lymphedema, and other edematous conditions can often result in the pooling of bodily fluids in areas of the body distal from the heart. Venous insufficiency can result when the superficial veins of an extremity empty into the deep veins of the lower leg. Normally, the contractions of the calf muscles act as a pump, moving blood into the popliteal vein, the outflow vessel. Failure of this pumping action can occur as a result of muscle weakness, overall chamber size reduction, valvular incompetence, and/or outflow obstruction. Each of these conditions can lead to venous stasis and hypertension in the affected area. Lymphedema, which is swelling due to a blockage of the lymph passages, may be caused by lymphatic obstruction, a blockage of the lymph vessels that drain fluid from tissues throughout the body. This is most commonly due to cancer surgery, general surgery, tumors, radiation treatments, trauma and congenital anomalies. Lymphedema is a chronic condition that currently has no cure.
Fluid accumulation can be painful and debilitating if not treated. Fluid accumulation can reduce oxygen transport, interfere with wound healing, provide a medium that support infections, or even result in the loss of a limb if left untreated.
Compression therapy devices are often used in the treatment of venous insufficiency by moving the accumulated bodily fluids. Additional conditions may also benefit from the use of compression therapy devices. Such devices typically include an air compressor that may blow air through tubes to an appliance such as a sleeve or boot containing a number of separately inflatable cells that is fitted over a problem area (such as an extremity or torso). Such devices may also include pneumatic components adapted to inflate and exhaust the cells, and control circuitry governing the pneumatic components. A therapeutic cycle or protocol may involve, for example, sequential inflation of the cells to a pre-set pressure in a distal to a proximal order, followed by exhausting all the cells in concert.
Multiple compression therapy sessions may be required to help maintain proper fluid flow in the patient over time. While such therapy sessions may be provided under supervision by a therapist or physician at a clinic or hospital, it may be more practical to have the patient self-administer the therapy at home using rented therapy equipment. Home therapy has the advantage of being more convenient for the patient, who may schedule the therapy sessions at will and who will not need to travel to a medical facility for the sessions. In addition, home therapy has the economic advantage of not requiring the time and resources of either medical personnel or facilities.
A potential disadvantage of home therapy, however, is a lack of patient compliance. A therapeutic session may be uncomfortable, and a patient may not feel motivated to take time from his or her schedule to perform the therapy. Patient compliance is important to several parties associated with the therapy. The manufacturer or supplier of the equipment may want to monitor patient use of the equipment as part of ongoing post-sales quality assurance. The physician and/or therapist may want to monitor compliance as part of their overall monitoring of patient health. By assessing a patient's health status over time and knowing the level of patient therapy compliance, a physician may be able to determine if a change in the therapeutic protocol may be required. In addition, health insurers may reimburse the companies providing the therapeutic device and/or disposable items associated with it. The insurers, however, may reimburse for equipment rentals only if the equipment is actually in use. Other individuals and organizations may have an interest in patient compliance, including, as non-limiting examples, researchers, family members, clinical trial registries, and accountable care organizations (ACO). It is therefore important to assure patient compliance in using such a compression therapy device.